Minoxidil gel

Abstract

PCT No. PCT/US88/00403 Sec. 371 Date Aug. 17, 1990 Sec. 102(e) Date Aug. 17, 1990 PCT Filed Feb. 18, 1988.The present invention provides a novel pharmaceutically acceptable gel containing minoxidil for topical application.

I claim: 
     
       1. A pharmaceutically-acceptable gel composition comprising the following components:   ______________________________________                                    
Component            Amount (% w/w)                                       
______________________________________                                    
(a) water                q.s. 100                                         
(b) carbomer             0.25-1.5                                         
(c) minoxidil            0.001-3                                          
(d) pharmaceutically-accetable glycol                                     
                         0.01-30                                          
(e) ethanol or isopropanol                                                
                          20-40                                           
(f) a water and alcohol-soluble amine                                     
                         0.25-1.5                                         
______________________________________                                    
     wherein the ratio of minoxidil to the glycol is sufficient for a saturated solution of minoxidil.   
     
     
       2. A gel of claim 1, wherein the amine is diisopropanolamine (DIPA), the alcohol is ethanol, the water is purified, and the glycol is propylene glycol. 
     
     
       3. A gel of claim 2, wherein the amount of minoxidil is 1.0%, the amount of carbomer is 0.45%, the amount of propylene glycol is 10%, the amount of ethanol is 40%, and the amount of DIPA is 0.45%. 
     
     
       4. A gel of claim 2, wherein the amount of minoxidil is 2.0%, the amount of carbomer is 0.5%, the amount of propylene glycol is 20%, the amount of ethanol is 40%, and the amount of DIPA is 0.5%. 
     
     
       5. A gel of claim 2, wherein the amount of minoxidil is 3%, the amount of carbomer is 0.5%, the amount of propylene glycol is 30%, the amount of ethanol is 40%, and the amount of DIPA is 0.5%. 
     
     
       6. A gel of any preceding claim, wherein the carbomer has a molecular weight approximately 3×10 6 . 
     
     
       7. A process for preparing a gel of any preceding claim, which comprises a first step of mixing the water, the carbomer, 5 to 27.1% w/w of the alcohol, and 0 to 0.04% w/w of the amine; and a subsequent second step of mixing, until a uniform gel is obtained, the mixture of the first step with the minoxidil, the glycol, 12.9 to 30% w/w of the alcohol, and the or the remainder of the amine; the percentages being with respect to the total composition. 
     
     
       8. A process of claim 7, wherein no amine is present in the first step. 
     
     
       9. A process of claim 8, for preparing a gel of claims 4 or 5, wherein the first step comprises mixing the water, a carbomer of approximate molecular weight of 3×10 6  and 27% w/w of the ethanol.